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A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52L in Healthy Volunteers

Sponsor
AJU Pharm Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05077475
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
7.2
Anticipated Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and pharmacokinetic characteristics of AJU-C52L in healthy adults

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This study is to assess the safety and pharmacokinetic characteristics between co-administration of C52R1H with C52R2 and administration of AJU-C52L.

This is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AJU-C52L Compared to Coadministration of C52R1H With C52R2 in Healthy Adult Volunteers
Actual Study Start Date :
Sep 24, 2021
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence A

Period 1: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose

Drug: C52R1H Tab. and C52R2 Tab.
Single oral dose C52R1H(FDC, Valsartan/Amlodipine) 160/10 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
Other Names:
  • Reference Drug

    • Drug: AJU-C52L
    Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 80/5/12.5 mg FDC 2 tablet
    Other Names:
  • Test Drug

    		•
    Experimental: Sequence B

    Period 1: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose

    Drug: C52R1H Tab. and C52R2 Tab.
    Single oral dose C52R1H(FDC, Valsartan/Amlodipine) 160/10 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
    Other Names:
  • Reference Drug

    • Drug: AJU-C52L
    Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 80/5/12.5 mg FDC 2 tablet
    Other Names:
  • Test Drug

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUCt of AJU-C52 [Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]

      Area under the concentration-time curve from time zero to time

    2. Cmax of AJU-C52 [Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]

      Cmax: Maximum plasma concentration of the drug

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Healthy adult volunteers aged ≥ 19-year-old

    2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2

    3. Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg

    4. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings

    5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests

    6. Those who agree to contraception during the participation of clinical trial

    7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

    Exclusion Criteria:

    1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug

    2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug

    3. Those who donated whole blood and apheresis within 8 weeks or received transfusion within 4 weeks

    4. Those who has a history of gastrointestinal surgery

    5. Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30 mL) Smoke: 20 cigarettes/day

    6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema

    7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption

    8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

    9. Women who are pregnant or who may be pregnant and breastfeed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 H+ Yangji Hospital Seoul Republic Of South Korea Korea, Republic of

    Sponsors and Collaborators

    • AJU Pharm Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AJU Pharm Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05077475
    Other Study ID Numbers:
    • 21HT10603
    First Posted:
    Oct 14, 2021
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Cryptophycin 52

    Study Results

    No Results Posted as of Oct 14, 2021